BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PANEL

    MDR report key: 1243080 · Received November 21, 2008

    Report

    Report Number
    2027969-2008-00039
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 21, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER BELIEVES TROPONIN I (TNI) RESULTS ON TRIAGE CARDIO PANEL TO BE DISCREPANT COMPARED TO RESULTS FROM ROCHE ULTRA SENSITIVE TN1. THE FIRST DRAW WAS MISTAKENLY RUN IN LAB ON ROCHE HIGH SENSITIVITY TNI WITH A RESULT OF 0.04. AN HOUR LATER, A SECOND SAMPLE WAS DRAWN AND RUN ON BOTH TRIAGE AND ROCHE. TRIAGE RESULTS: TNI 0.22, CKMB 3.4, MYO 70.4 AND ROCHE TNI: 0.08. THE EMERGENCY DEPT. USES AND EQUIVOCAL RANGE OF 0.05 - 0.4 FOR TNI. THE PAIRED EDTA TUBE FROM THE FIRST DRAW WAS LOCATED AND RUN APPROXIMATELY 24 HOURS LATER, AND THE TRIAGE TNI RESULT WAS 0.15. CUSTOMER FEELS THAT THIS REPLICATES THE ORIGINAL RESULT OF 0.22 CONSIDERING THAT THE SAMPLE HAD BEEN AT ROOM TEMP FOR ALMOST 24 HOURS. THERE IS NO SAMPLE OR USED DEVICES AVAILABLE FOR INVESTIGATION. PATIENT WAS NOT ADMITTED, AND NO OTHER INFORMATION ON POSSIBLE TREATMENT IS AVAILABLE. FALSELY ELEVATED TNI RESULTS MAY LEAD TO INVASIVE PROCEDURE OR MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97100HS W43571

    Patients

    Seq Age Sex Outcome Treatment
    1